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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Preloop trial: study protocol for a randomized controlled trial

Authors: Elisa Mäkäräinen-Uhlbäck, Heikki Wiik, Jyrki Kössi, Pasi Ohtonen, Tero Rautio

Published in: Trials | Issue 1/2018

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Abstract

Background

A temporary loop ileostomy, which is used to decrease the risk of symptomatic anastamotic leakage after anterior resection and total mesorectal excision (TME), is traditionally closed without any mesh. However, as 44% of incisional site hernias need further repair after stoma closure, attention has increasingly been paid to the use of mesh. Research on the prevention of these hernias is scarce, and no studies comparing different meshes exist.

Method/Design

The Preloop trial (Clinical Trials NCT03445936) is a prospective, randomized, controlled, multicenter trial to compare synthetic mesh (Parietene Macro™, Medtronic, Minneapolis, MN, USA) and biological implants (Permacol™, Medtronic) at a retromuscular sublay position for the prevention of incisional site hernias after loop-ileostomy closure. The main endpoints in this trial are infections at 30-day follow-up and the incidence of hernias clinically or on CT scan at 10 months after closure of the stoma. The secondary endpoints are other complications within 30 days of surgery graded with the Clavien-Dindo classification, reoperation rate, operating time, length of stay, quality of life measured with RAND-36, and incidence of hernia over a 5-year follow-up period. A total of 100 patients will be randomized in a 1:1 ratio.

Discussion

This is a pilot trial that will be undertaken to provide some novel evidence on the safety profile and efficiency of both synthetic mesh and biological implants for the prevention of incisional hernias after closure by temporary loop ileostomy. The hypothesis is that synthetic mesh is economical but equally safe and at least as effective as biological implants in hernia prevention and in contaminated surgical sites.

Trial Registration

ClinicalTrials.gov, NCT03445936. Registered on 7 February 2018.
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Metadata
Title
Preloop trial: study protocol for a randomized controlled trial
Authors
Elisa Mäkäräinen-Uhlbäck
Heikki Wiik
Jyrki Kössi
Pasi Ohtonen
Tero Rautio
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2977-9

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